JP6457985B2 - Medical knife - Google Patents

Medical knife Download PDF

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JP6457985B2
JP6457985B2 JP2016166623A JP2016166623A JP6457985B2 JP 6457985 B2 JP6457985 B2 JP 6457985B2 JP 2016166623 A JP2016166623 A JP 2016166623A JP 2016166623 A JP2016166623 A JP 2016166623A JP 6457985 B2 JP6457985 B2 JP 6457985B2
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tip
virtual
incision
angle
knife
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JP2018033492A (en
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祥亨 田澤
祥亨 田澤
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Mani Inc
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Mani Inc
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Priority to JP2016166623A priority Critical patent/JP6457985B2/en
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Priority to PCT/JP2017/030255 priority patent/WO2018043266A1/en
Priority to KR1020197006536A priority patent/KR102415173B1/en
Priority to MX2019002270A priority patent/MX2019002270A/en
Priority to US16/325,722 priority patent/US11304849B2/en
Priority to AU2017321548A priority patent/AU2017321548B2/en
Priority to EP17846271.9A priority patent/EP3498202B1/en
Priority to CN201780052427.8A priority patent/CN109661206B/en
Priority to BR112019004245-8A priority patent/BR112019004245B1/en
Priority to RU2019108820A priority patent/RU2744554C2/en
Publication of JP2018033492A publication Critical patent/JP2018033492A/en
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Priority to IL264600A priority patent/IL264600B/en
Priority to CONC2019/0002642A priority patent/CO2019002642A2/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/013Instruments for compensation of ocular refraction ; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea
    • A61F9/0133Knives or scalpels specially adapted therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3209Incision instruments
    • A61B17/3211Surgical scalpels, knives; Accessories therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017Angular shapes

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgical Instruments (AREA)

Description

本発明は眼科手術に際し、高い自己閉鎖性を有する切開創を実現し得るようにした医療用ナイフに関するものである。   The present invention relates to a medical knife capable of realizing an incision having high self-closing property in ophthalmic surgery.

眼科手術では、医療用ナイフを球面状の眼球に刺し込んで角膜又は角膜と強膜の間を切開する際に自己閉鎖性の高い切開創を形成することが好ましいとされている。自己閉鎖性の高い切開創とは、眼球を正面からみたとき、中心に向かって凸となる緩やかな曲線状の所謂フラウン切開である。   In ophthalmic surgery, it is preferable to form a highly self-closing incision when a medical knife is inserted into a spherical eyeball and an incision is made between the cornea or cornea and sclera. An incision with high self-closing property is a so-called Fraun incision having a gently curved shape that is convex toward the center when the eyeball is viewed from the front.

眼科手術に使用される医療用ナイフとして、断面形状がエッジを結ぶ面を底面とする台形状に形成されたべベルアップ型、エッジを結ぶ線が略中間位置にある算盤玉状に形成されたバイべベル型、などが提供され、夫々選択的に使用されている。   As a medical knife used in ophthalmic surgery, a bevel-up type whose cross-sectional shape is formed in a trapezoidal shape with the surface connecting the edges as the bottom surface, a bi-layer formed in an abacus bead shape in which the lines connecting the edges are at approximately intermediate positions A bevel type and the like are provided and are used selectively.

べベルアップ型のナイフの場合、切開時に作用する眼圧及び切開抵抗によって生じる力が上面と下面で異なり、切開の進行に伴って下向きに作用する力が大きくなって、全体に底面方向にずれるという特徴を有する。このナイフは比較的高い自己閉鎖性を有する切開創を形成することができる。また、バイべベル型のナイフの場合、切開時に上面と下面に作用する力は略等しくなり、差し込み方向は直線的になるという特徴を有するものの、形成された切開創の自己閉鎖性はさほど高くはない。   In the case of a bevel-up type knife, the force generated by the intraocular pressure and the incision resistance acting at the time of incision differs between the upper surface and the lower surface, and the force acting downward as the incision progresses increases and shifts toward the bottom as a whole. It has the characteristics. This knife can form an incision with a relatively high self-closing property. In addition, in the case of a bevel-type knife, the forces acting on the upper surface and the lower surface are substantially equal during incision, and the insertion direction is linear, but the self-closing property of the formed incision is very high. There is no.

常に、より好ましい切開創を形成し得る医療用ナイフの開発が要求されており、この要求に応えて特許文献1に記載された医療用ナイフが提案されている。この医療用ナイフは、自己閉鎖性の高い切開創を形成することを目的として開発されたものであり、刃部の先端部分に形成した鋭い尖端を頂点とし、菱形の最大幅の部分にまでエッジが形成されている。   Development of a medical knife capable of forming a more preferable incision is always required, and the medical knife described in Patent Document 1 has been proposed in response to this request. This medical knife was developed for the purpose of forming a highly self-closing incision, with the sharp tip formed at the tip of the blade as the apex and the edge up to the maximum width of the rhombus Is formed.

そして、エッジを含む面を境界として上部側にエッジから内部側に向かい厚さ方向に傾斜した第1傾斜面と、この第1傾斜面に連続した第2傾斜面とが形成され、最も上部側の表面が上部平面として形成されている。また、エッジを含む面を境界として下部側にはエッジから刃部の内部側に向かい厚さ方向に傾斜した下側傾斜面と、この下側傾斜面に連続した平面が形成されている。特に、エッジを含む面を境界として上部面側の厚みが刃部に於ける総厚みの75%〜93%の範囲となるように構成されている。   Then, a first inclined surface inclined in the thickness direction from the edge toward the inner side with the surface including the edge as a boundary, and a second inclined surface continuous with the first inclined surface are formed, and the uppermost side is formed. Is formed as an upper plane. Further, a lower inclined surface inclined in the thickness direction from the edge toward the inner side of the blade portion and a plane continuous to the lower inclined surface are formed on the lower side with the surface including the edge as a boundary. In particular, the thickness on the upper surface side is set to be in the range of 75% to 93% of the total thickness in the blade portion with the surface including the edge as a boundary.

上記医療用ナイフでは、角膜又は角膜と強膜の間を切開する際に、尖端を球面上の角膜に刺し込んだときに作用する眼圧や切開抵抗によって、上面側に作用する力が下面側に作用する力よりも大きくなるもののその差は小さい。このため、医療用ナイフの刺し込み方向からみた切開創は上に向けて凸となる緩やかな曲線となる。また、眼球の正面から見た切開創は、眼球の中心に向けて凸となる更に緩やかな曲線となる。このような切開創は、自己閉鎖性の高い好ましいものである。   In the medical knife described above, when incising between the cornea or the cornea and the sclera, the force acting on the upper surface side is caused by the intraocular pressure and the incision resistance acting when the tip is inserted into the cornea on the spherical surface. The difference is small, although it is greater than the force acting on. For this reason, the incision seen from the insertion direction of the medical knife has a gentle curve that is convex upward. In addition, the incision seen from the front of the eyeball is a more gentle curve that is convex toward the center of the eyeball. Such an incision is preferable because of its high self-closing property.

特許第4269299号公報(特開2001−238890)Japanese Patent No. 4269299 (Japanese Patent Laid-Open No. 2001-238890)

上記特許文献1に記載された医療用ナイフでは、眼科手術の際に自己閉鎖性の高い切開創を形成することができる。しかし、常により良い切開創を形成することができる医療用ナイフの開発が求められているのが実情である。   With the medical knife described in Patent Document 1, an incision with high self-closing property can be formed during ophthalmic surgery. However, there is a demand for the development of a medical knife that can always form a better incision.

本発明の目的は、より高い自己閉鎖性を有する切開創を形成することができる医療用ナイフを提供することにある。   An object of the present invention is to provide a medical knife capable of forming an incision having a higher self-closing property.

上記課題を解決するために本発明に係る医療用ナイフは、刃部の外周に沿ってエッジを形成した医療用ナイフであって、刃部の平面投影形状が、刃部の先端部分に形成された尖端及び該尖端の近傍を含む先端部と、最も幅の広い最大幅部と、先端部と最大幅部の間に形成された側面部とからなる略三角形に形成され、且つ刃部の外周に沿って形成されたエッジを含む仮想面を境界とし、表面側にエッジを構成する表面側斜面が、裏面側にエッジを構成する裏面側斜面が夫々形成されており、前記先端部に於ける前記仮想面と前記表面側斜面とのなす角度に対する前記仮想面と前記裏面側斜面とのなす角度の割合が、前記側面部に於ける前記表面側斜面とのなす角度に対する前記仮想面と前記裏面側斜面とのなす角度の割合よりも大きいことを特徴とするものである。
In order to solve the above problems, a medical knife according to the present invention is a medical knife in which an edge is formed along the outer periphery of the blade portion, and the planar projection shape of the blade portion is formed at the tip portion of the blade portion. The outer periphery of the blade portion is formed in a substantially triangular shape including a tip portion including the tip and the vicinity of the tip, the widest maximum width portion, and a side surface portion formed between the tip portion and the maximum width portion. A front side slope that constitutes an edge on the front side and a back side slope that constitutes an edge on the back side are respectively formed with a virtual plane including an edge formed along the boundary as a boundary. The ratio of the angle formed between the virtual surface and the back surface side slope to the angle formed between the virtual surface and the surface side slope is the virtual surface and the back surface relative to the angle formed between the front surface side slope in the side surface portion. Be larger than the ratio of the angle with the side slope. It is an butterfly.

上記医療用ナイフに於いて、前記仮想面を境界とし、該仮想面の表面側の厚みが前記裏面側の厚みよりも大きいことが好ましい。 In the medical knife, it is preferable that the virtual surface is a boundary, and the thickness of the front surface side of the virtual surface is larger than the thickness of the back surface side.

また、上記何れかの医療用ナイフに於いて、前記仮想面と前記表面側斜面とのなす角度に対する前記仮想面と前記裏面側斜面とのなす角度の割合は、前記側面部では略一定であることが好ましい。   In any one of the medical knives described above, a ratio of an angle formed by the virtual surface and the back-side inclined surface to an angle formed by the virtual surface and the front-side inclined surface is substantially constant at the side surface portion. It is preferable.

本発明に係る医療用ナイフ(以下単に「ナイフ」という)では、高い自己閉鎖性を発揮する切開創を形成することができる。   The medical knife (hereinafter simply referred to as “knife”) according to the present invention can form an incision that exhibits high self-closing properties.

刃部の外周に沿って形成されたエッジを含む仮想面を境界として、表面側に形成された表面側斜面と仮想面とのなす角度に対する裏面側に形成された裏面側斜面と仮想面とのなす角度の割合が、先端部の方が側面部よりも大きい。このため、眼球を切開する際に作用する眼圧や切開抵抗によって表面側から裏面側に生じる力の差は、先端部の方が小さくなり、側面部の方が大きくなる。   With the virtual plane including the edge formed along the outer periphery of the blade part as a boundary, the back-side slope and the virtual plane formed on the back side with respect to the angle formed by the front-side slope and the virtual plane formed on the front side The ratio of the angle formed is greater at the tip than at the side. For this reason, the difference in force generated from the front surface side to the back surface side due to intraocular pressure or incision resistance acting when the eyeball is incised is smaller at the tip portion and larger at the side portion.

従って、眼球を切開する際に、先端部ではナイフを裏面側に下げようとする力が小さく、直進させようとする力が大きくなり、曲率の小さい曲線状の切開創を形成することができる。また、側面部ではナイフを裏面側に下げようとする力が先端部よりも大きくなり、曲率の大きい曲線状の切開創を形成することができる。このようにして自己閉鎖性の高い切開創を形成することができる。   Accordingly, when the eyeball is incised, the force for lowering the knife to the back side is small at the tip, and the force for moving straight is increased, so that a curved incision with a small curvature can be formed. In addition, a force for lowering the knife to the back side is greater at the side surface than at the tip, and a curved incision with a large curvature can be formed. In this way, a highly self-closing incision can be formed.

特に、エッジを含む仮想線を境界とし、該仮想面の表面側の厚みが前記裏面側の厚みよりも大きくすることで、眼球を切開する際に表面側に作用する力と裏面側に作用する力との差を小さくすることができる。   In particular, when the imaginary line including the edge is used as a boundary and the thickness on the front surface side of the virtual surface is larger than the thickness on the back surface side, the force acting on the front surface side and the back surface side when the eyeball is incised. The difference with force can be reduced.

また、仮想面と表面側斜面とのなす角度に対する仮想面と裏面側斜面とのなす角度の割合を、側面部では略一定とすることで、眼球に対してナイフを刺し込んだとき、側面部に於ける裏面側に下げるように作用する力を略一定の値とすることができる。このため、医師が安定した状態で切開手術を進めることができる。   In addition, the ratio of the angle formed by the virtual surface and the back surface side slope to the angle formed by the virtual surface and the front surface side slope is substantially constant at the side surface, so that when the knife is inserted into the eyeball, the side surface portion The force acting so as to lower the back surface side can be set to a substantially constant value. For this reason, the doctor can proceed with the incision operation in a stable state.

第1実施例に係るナイフの表面と裏面を示す図である。It is a figure which shows the surface and back surface of the knife which concern on 1st Example. 図1の部分断面図である。It is a fragmentary sectional view of FIG. エッジ部分の拡大図である。It is an enlarged view of an edge part. 第2実施例に係るナイフの表面と裏面を示す図である。It is a figure which shows the surface and back surface of the knife which concern on 2nd Example.

以下、本発明に係るナイフについて説明する。本発明に係るナイフは、眼球を切開したとき、高い自己閉鎖性を有する切開創を形成することを可能としたものである。   Hereinafter, the knife according to the present invention will be described. The knife according to the present invention makes it possible to form an incision having high self-closing properties when an eyeball is incised.

本発明に係るナイフは、眼球に刺し込んで初期切開創を形成し、この初期切開創を起点として切開すると共に押し広げる機能を有する。そして、眼球にレンズを埋設するような手術を実施するに際し、該眼球から水晶体を吸引するための超音波乳化吸引装置のチップを挿入し、或いは該眼球に埋め込むレンズを挿入し得る長さの切開創を形成するものである。   The knife according to the present invention has a function of piercing the eyeball to form an initial incision, incising and expanding the initial incision as a starting point. Then, when performing an operation to embed a lens in the eyeball, insert a chip of an ultrasonic emulsification suction device for sucking the crystalline lens from the eyeball, or cut a length that allows insertion of a lens to be embedded in the eyeball. It forms a wound.

本発明に係るナイフを構成する材料として特に限定するものではなく、ステンレス鋼や炭素鋼等の鋼類を用いることが可能である。しかし、防錆の面や加工のし易さを考慮したとき、ステンレス鋼であることが好ましく、中でもオーステナイト系ステンレス鋼であることが望ましい。   It does not specifically limit as a material which comprises the knife which concerns on this invention, Steels, such as stainless steel and carbon steel, can be used. However, considering the antirust surface and the ease of processing, stainless steel is preferable, and austenitic stainless steel is particularly preferable.

オーステナイト系ステンレス鋼を素材とする場合、素材の硬度を上昇させるために、所定の加工率で冷間塑性加工を施して組織をファイバー状に伸長させておき、ファイバー状の組織を維持してプレス加工、研磨加工及び他の必要な加工を施すことが好ましい。   When using austenitic stainless steel as a raw material, in order to increase the hardness of the raw material, cold plastic working is performed at a predetermined processing rate to stretch the structure into a fiber shape, and the fiber-like structure is maintained and pressed. It is preferable to perform processing, polishing, and other necessary processing.

本発明に係るナイフは、刃部の平面形状が、鋭い尖端と該尖端の近傍を含む先端部と、最大幅部と、先端部と最大幅部の間に形成された側面部と、を有する略菱形に形成されている。そして、尖端から最大幅部に至る外周部分にエッジ(切刃)が形成されている。このため、眼球に尖端を刺し込んでまっすぐに移動させることで最大幅部の寸法に対応する切開創を形成することが可能である。また、眼球に尖端を差し込んで左右方向に移動させることで、最大幅部の寸法の如何に関わらず所望の幅の切開創を形成することが可能である。   In the knife according to the present invention, the planar shape of the blade portion includes a sharp tip, a tip including the vicinity of the tip, a maximum width, and a side portion formed between the tip and the maximum width. It is formed in a roughly diamond shape. And the edge (cutting blade) is formed in the outer peripheral part from a point to the maximum width part. For this reason, it is possible to form an incision corresponding to the dimension of the maximum width portion by inserting the tip into the eyeball and moving it straight. In addition, it is possible to form an incision having a desired width regardless of the size of the maximum width portion by inserting a tip into the eyeball and moving it in the left-right direction.

本発明に係るナイフに於いて、先端部を構成する尖端の近傍とは、尖端を頂点とし最大幅部のエッジどうしを結ぶ線を底辺とする三角形を想定し、尖端から底辺に至る垂線(軸線ともいう)の長さの1/2までの範囲、好ましくは1/4までの範囲である。先端部を構成する尖端を含む尖端の近傍の長さが、尖端から底辺に至る垂線の長さの1/2を超えると、従来のバイべベル型のナイフによる切開創と類似の切開創となり、好ましくない。また、尖端から底辺に至る垂線の長さの1/4よりも小さい1/30程度以下になると、切開を開始した際に生じるナイフの直進性を発揮し得る範囲が狭くなり、高い自己切開性を有する切開創を形成し得なくなる。   In the knife according to the present invention, the vicinity of the apex constituting the tip is assumed to be a triangle having the apex at the apex and the line connecting the edges of the maximum width portion as the base, and a perpendicular (axis line from the apex to the base) The range of up to ½, preferably up to ¼. If the length of the vicinity of the apex, including the apex that forms the tip, exceeds 1/2 of the length of the perpendicular from the apex to the base, an incision similar to a conventional beveled knife incision is formed. It is not preferable. In addition, when the length is about 1/30 or less smaller than ¼ of the length of the perpendicular line from the apex to the base, the range in which the straightness of the knife that occurs when incision starts can be reduced, and high self-incision property An incision with no can be formed.

更に本発明に係るナイフは、尖端を頂点として刃部の外周に沿って形成された一対のエッジを含む仮想面を想定し、この仮想面を境界として表面側に表面側斜面が形成され、裏面側に裏面側斜面が形成されている。そして、先端部に於ける仮想面と表面側斜面とのなす角度に対する仮想面と裏面側斜面とのなす角度の割合(先端部に於ける角度の割合)が、側面部に於ける表面側斜面とのなす角度に対する仮想面と裏面側斜面とのなす角度の割合(側面部に於ける角度の割合)よりも大きく構成されている。   Further, the knife according to the present invention assumes a virtual surface including a pair of edges formed along the outer periphery of the blade portion with the apex as the apex, and a surface-side inclined surface is formed on the surface side with this virtual surface as a boundary. A back side slope is formed on the side. The ratio of the angle between the imaginary surface and the back-side slope to the angle between the imaginary surface and the surface-side slope at the tip (the ratio of the angle at the tip) is the surface-side slope at the side. Is larger than the ratio of the angle formed by the imaginary plane and the back-side inclined surface to the angle formed by (the ratio of the angle at the side surface).

先端部に於ける角度の割合が、側面部に於ける角度の割合よりどの程度大きいかは特に限定するものではなく、眼科手術を行う際に、先端部では十分な直進性を発揮し、側面部では適度な下向きの力が作用し得るような割合であることが好ましい。即ち、先端部ではバイべベル型のナイフの特性を有し、側面部ではべベルアップ型の特性を有するような割合に設定することが好ましい。   There is no particular limitation on how much the angle ratio at the tip portion is larger than the angle ratio at the side surface portion. When performing ophthalmic surgery, the tip portion exhibits sufficient straightness and the side surface. It is preferable that the ratio is such that a moderate downward force can act on the part. That is, it is preferable to set the ratio so that the tip portion has characteristics of a bevel-type knife and the side portion has bevel-up type characteristics.

先端部に於ける角度の割合を側面部に於ける角度の割合よりも大きくする場合、先端部に於ける仮想面に対する表面側斜面のなす角度、先端部に於ける仮想面に対する裏面側斜面のなす角度、側面部に於ける仮想面に対する表面側斜面のなす角度、側面部に於ける仮想面に対する裏面側斜面のなす角度、を夫々独立させた角度として設定することで実現することが可能である。   When the ratio of the angle at the tip is larger than the ratio of the angle at the side, the angle formed by the front-side slope with respect to the virtual surface at the tip, and the back-side slope with respect to the virtual surface at the tip This can be achieved by setting the angle to be made, the angle made by the front side slope to the virtual surface at the side surface, and the angle made from the back side slope to the virtual surface at the side surface as independent angles. is there.

例えば、先端部及び側面部に於ける仮想面に対する表面側斜面のなす角度を一定とし、先端部に於ける仮想面に対する裏面側斜面のなす角度を、側面部に於ける仮想面に対する裏面側斜面のなす角度よりも大きく設定することで実現することが可能である。或いは、先端部に於ける仮想面に対する表面側斜面のなす角度を、側面部に於ける仮想面に対する表面側斜面のなす角度よりも小さくし、先端部及び側面部に於ける仮想面に対する裏面側斜面のなす角度を一定としても実現することが可能である。   For example, the angle formed by the front surface slope with respect to the virtual surface at the front end portion and the side surface portion is constant, and the angle formed by the rear surface side slope with respect to the virtual surface at the front end portion is set as the back surface side slope with respect to the virtual surface at the side surface portion. It can be realized by setting it larger than the angle formed by Alternatively, the angle formed by the surface side slope with respect to the virtual surface at the front end portion is smaller than the angle formed by the surface side slope with respect to the virtual surface at the side surface portion, and the back surface side with respect to the virtual surface at the tip portion and side surface portion. It can be realized even if the angle formed by the slope is constant.

また、仮想面を境界として表面側の厚みが裏面側の厚みよりも大きいことが好ましい。表面側の厚みが裏面側の厚みよりもどの程度大きいかは特に限定するものではなく、眼球に側面部が刺し込まれたとき、作用する下向きの力が自己閉鎖性を有する切開創を形成し得るような厚みであることが好ましい。   Moreover, it is preferable that the thickness on the front surface side is larger than the thickness on the back surface side with the virtual surface as a boundary. There is no particular limitation on how much the thickness on the front side is greater than the thickness on the back side, and when the side part is inserted into the eyeball, the downward force acting acts to form a self-closing incision. It is preferable that the thickness be obtained.

また、側面部では、仮想面と表面側斜面とのなす角度に対する仮想面と裏面側斜面とのなす角度の割合を略一定とすることが好ましい。この場合、側面部に於ける表面側に作用する力と裏面側に作用する力の差が略一定となる。このため、単位長さ差し込んだときの裏面方向への移動寸法が略一定となり、安定した曲率を有する曲線からなる切開創を形成することが可能となる。   In the side surface portion, it is preferable that the ratio of the angle formed by the virtual surface and the back surface side slope to the angle formed by the virtual surface and the front surface side slope is substantially constant. In this case, the difference between the force acting on the front surface side and the force acting on the back surface side in the side surface portion is substantially constant. For this reason, the movement dimension in the back surface direction when the unit length is inserted becomes substantially constant, and it becomes possible to form an incision made of a curve having a stable curvature.

次に図1〜図3を用いてナイフの第1実施例について説明する。本実施例に係るナイフは、先端部及び側面部に於ける仮想面に対する表面側斜面のなす角度を一定とし、先端部に於ける仮想面に対する裏面側斜面のなす角度を側面部に於ける仮想面に対する裏面側斜面のなす角度よりも大きく設定している。   Next, a first embodiment of the knife will be described with reference to FIGS. In the knife according to the present embodiment, the angle formed by the front-side inclined surface with respect to the virtual surface at the front end portion and the side surface portion is constant, and the angle formed between the rear surface-side inclined surface with respect to the virtual surface at the front end portion is the virtual angle at the side surface portion. It is set to be larger than the angle formed by the back side slope with respect to the surface.

図に於いて、ナイフAは、刃部1と、この刃部1に連続した図示しないシャンクを有して構成されている。刃部1には鋭い尖端2が形成されており、該尖端2及び該尖端2の近傍を含んで先端部3が形成されている。また、尖端2から離隔した位置に刃部1の最大幅部4が形成されており、先端部3から最大幅部4の間が側面部5として形成されている。   In the drawing, the knife A is configured to have a blade portion 1 and a shank (not shown) continuous with the blade portion 1. A sharp tip 2 is formed on the blade portion 1, and a tip 3 is formed including the tip 2 and the vicinity of the tip 2. A maximum width portion 4 of the blade portion 1 is formed at a position separated from the tip 2, and a portion between the tip portion 3 and the maximum width portion 4 is formed as a side surface portion 5.

尖端2から最大幅部4までの距離、最大幅部4の幅寸法等の詳細な寸法、及び先端部3の範囲はナイフAの目的、例えば切開創の寸法等の仕様に応じて種々設定されている。   The distance from the tip 2 to the maximum width portion 4, the detailed dimensions such as the width dimension of the maximum width portion 4, and the range of the tip 3 are variously set according to the purpose of the knife A, for example, the specifications of the incision, etc. ing.

刃部1の外周に沿って、尖端2を頂点とし最大幅部4に至る一対のエッジ7が形成されている。このエッジ7は生体組織を切り開く機能を有するものであり、刃部1の外周に沿って形成された一対のエッジ7を含む仮想面7aを境界として表面側に形成された表面側斜面8と裏面側に形成された裏面側斜面9とが交差することで形成されている。このように、表面側斜面8と裏面側斜面9は共同してエッジ7を形成するものであるため、これらの斜面8、9は平滑度の高い研削面として形成されている。   A pair of edges 7 are formed along the outer periphery of the blade portion 1 with the tip 2 as a vertex and reaching the maximum width portion 4. The edge 7 has a function of cutting the living tissue, and the surface-side inclined surface 8 and the back surface formed on the surface side with a virtual surface 7a including a pair of edges 7 formed along the outer periphery of the blade portion 1 as a boundary. It is formed by crossing the back side slope 9 formed on the side. Thus, since the front surface side slope 8 and the back surface side slope 9 jointly form the edge 7, these slopes 8 and 9 are formed as a ground surface with high smoothness.

刃部1に於ける表面側に形成された表面側斜面8に沿って第2斜面10が形成され、両斜面8、10の境界には境界線8aが形成されている。従って、第2斜面10は両エッジ7を構成する表面側斜面8の間に形成されている。第2斜面10は切刃としての機能を有することがないため、必ずしも高い平滑度を持った研削面によって形成する必要はなく、プレス面或いは粗い研削面であっても良い。   A second inclined surface 10 is formed along the surface-side inclined surface 8 formed on the surface side in the blade portion 1, and a boundary line 8 a is formed at the boundary between both the inclined surfaces 8 and 10. Accordingly, the second inclined surface 10 is formed between the surface-side inclined surfaces 8 constituting both edges 7. Since the second inclined surface 10 does not have a function as a cutting edge, it is not necessarily formed by a ground surface having high smoothness, and may be a pressed surface or a rough ground surface.

また、一対の第2斜面10の間に該第2斜面10に沿って表面側平面11が形成されている。この表面側平面11も第2斜面10と同様にプレス面或いは粗い研削面であっても良い。   A surface side plane 11 is formed between the pair of second slopes 10 along the second slope 10. The surface side plane 11 may also be a pressed surface or a rough ground surface like the second inclined surface 10.

尚、本実施例に於いては、第2斜面10及び表面側平面11を設けたが、第2斜面10、表面側平面11は必須なものではなく、これらを設けない構成とすることも可能である。例えば、表面側斜面8を刃部1の内側に延長させ中央で交叉させてもよく、第2斜面10を刃部1の内側に延長させ中央で交叉させてもよい。その場合の延長させる面は、平面でも曲面でも良い。   In the present embodiment, the second inclined surface 10 and the surface side plane 11 are provided, but the second inclined surface 10 and the surface side plane 11 are not indispensable, and a configuration without these is also possible. It is. For example, the front side inclined surface 8 may be extended inside the blade portion 1 and crossed at the center, and the second inclined surface 10 may be extended inside the blade portion 1 and crossed at the center. In this case, the surface to be extended may be a flat surface or a curved surface.

刃部1に於ける裏面側に形成された一対の裏面側斜面9の間に該裏面側斜面9に連続して裏面側平面12が形成されている。この裏面側平面12は、前述の第2斜面10及び表面側平面11と同様に切刃としての機能を有することのない面として形成される。このため、必ずしも高い平滑度を持った研削面である必要はなく、粗い研削面或いはプレス面として形成されていても良い。   A back side flat surface 12 is formed continuously between the back side slopes 9 between a pair of back side slopes 9 formed on the back side in the blade portion 1. The back surface side plane 12 is formed as a surface that does not have a function as a cutting edge, like the second inclined surface 10 and the surface side surface 11 described above. For this reason, it is not necessarily a ground surface with high smoothness, and it may be formed as a rough ground surface or a press surface.

先端部3は尖端2及び該尖端2の近傍を含んで形成されている。尖端2の近傍の範囲は限定するものではなく、眼科手術の際に必要とされる自己閉鎖性を発揮するのに適した切開創を形成し得る範囲であることが好ましい。   The tip 3 is formed including the tip 2 and the vicinity of the tip 2. The range in the vicinity of the tip 2 is not limited, and is preferably a range in which an incision suitable for exhibiting the self-closing property required for ophthalmic surgery can be formed.

本実施例では、最大幅部4を結ぶ線(図1(a)のC−C線)を底辺とし、尖端2を通る垂線(軸線)上で、尖端2から底辺までの寸法の約1/5の範囲を先端部3として設定している。しかし、この範囲に限定するものではなく、これ以上長くとも良く、また短くとも良い。   In the present embodiment, the line connecting the maximum width portions 4 (the CC line in FIG. 1A) is the bottom, and on the perpendicular (axis) passing through the tip 2, about 1 / of the dimension from the tip 2 to the base. A range of 5 is set as the tip 3. However, it is not limited to this range, and it may be longer or shorter.

前述したように、本実施例では、先端部3及び側面部5に於ける仮想面7aに対する表面側斜面8のなす角度を一定としている。そして、先端部3に於ける仮想面7aに対する裏面側斜面9aのなす角度を側面部5に於ける仮想面7aに対する裏面側斜面9bのなす角度よりも大きく設定している。   As described above, in the present embodiment, the angle formed by the surface side inclined surface 8 with respect to the virtual surface 7a at the tip portion 3 and the side surface portion 5 is constant. The angle formed by the back surface side inclined surface 9 a with respect to the virtual surface 7 a at the front end portion 3 is set larger than the angle formed by the back surface side inclined surface 9 b with respect to the virtual surface 7 a at the side surface portion 5.

特に、先端部3を構成する裏面側斜面9aから側面部5を構成する裏面側斜面9bに連続して移行し得るように、該移行部は平滑な曲面として形成されている。   In particular, the transition portion is formed as a smooth curved surface so that it can continuously transition from the back surface side inclined surface 9a constituting the tip portion 3 to the back surface side inclined surface 9b constituting the side surface portion 5.

次に、先端部3と側面部5に於ける仮想面7aを境界とする、先端部3に於ける仮想面7aと表面側斜面8とのなす角度と、仮想面7aと裏面側斜面9(9a、9b)とのなす角度の関係について説明する。   Next, the angle formed by the virtual surface 7a and the front surface side inclined surface 8 at the front end portion 3 with the virtual surface 7a at the front end portion 3 and the side surface portion 5 as a boundary, the virtual surface 7a and the rear surface side inclined surface 9 ( The relationship between the angles formed by 9a and 9b) will be described.

図2(a)は先端部3に於けるA−A断面図であり、図3(a)はエッジ7の拡大説明図である。図2(b)は側面部5に於けるB−B断面図であり、図3(b)はエッジ7の拡大説明図である。図2(c)は最大幅部4に於けるC−C断面図であり、図3(c)はエッジ7の拡大説明図である。   2A is a cross-sectional view taken along the line AA at the distal end portion 3, and FIG. 3A is an enlarged explanatory view of the edge 7. FIG. 2B is a cross-sectional view taken along the line BB in the side surface portion 5, and FIG. 3B is an enlarged explanatory view of the edge 7. 2C is a cross-sectional view taken along the line C-C in the maximum width portion 4, and FIG. 3C is an enlarged explanatory view of the edge 7.

図に示すように、先端部3に於けるエッジ7は、仮想面7aを境界とし、該仮想面7aに対し角度αで交差した表面側斜面8と、仮想面7aに対し角度βで交差した裏面側斜面9aと、によって構成されている。   As shown in the drawing, the edge 7 at the tip 3 crosses the virtual surface 7a at the angle α with the virtual surface 7a as a boundary and the surface-side inclined surface 8 that intersects the virtual surface 7a at the angle β. And a back side inclined surface 9a.

また、側面部5に於けるエッジ7は、仮想面7aを境界とし、該仮想面7aに対し角度αで交差した表面側斜面8と、仮想面7aに対し角度θで交差した裏面側斜面9bと、によって構成されている。更に、最大幅部4に於けるエッジ7は、仮想面7aを境界とし、該仮想面7aに対し角度αで交差した表面側斜面8と、仮想面7aに対し角度θで交差した裏面側斜面9と、によって構成されている。   Further, the edge 7 in the side surface portion 5 has the virtual surface 7a as a boundary, and the front surface side inclined surface 8 intersecting the virtual surface 7a at an angle α and the back surface side inclined surface 9b intersecting the virtual surface 7a at an angle θ. And is composed of. Further, the edge 7 in the maximum width portion 4 has a virtual surface 7a as a boundary, and a front-side slope 8 intersecting the virtual surface 7a at an angle α, and a back-side slope intersecting the virtual surface 7a at an angle θ. 9.

各角度α、β、θの値を限定するものではない。しかし、角度βは角度θよりも大きい角度に設定されている。即ち、先端部3のエッジ7に於ける仮想面7aと表面側斜面8とのなす角度αに対する仮想面7aと裏面側斜面9aとのなす角度βの割合はβ/αとなる。また、側面部5のエッジ7に於ける仮想面7aと表面側斜面8とのなす角度αに対する仮想面7aと裏面側斜面9bとのなす角度の割合はθ/αとなる。従って、先端部3に於ける割合β/αは、側面部5に於ける割合θ/αよりも大きい。   The values of the angles α, β, and θ are not limited. However, the angle β is set to be larger than the angle θ. That is, the ratio of the angle β formed between the virtual surface 7a and the back-side inclined surface 9a to the angle α formed between the virtual surface 7a and the front-side inclined surface 8 at the edge 7 of the tip 3 is β / α. Further, the ratio of the angle formed between the virtual surface 7a and the back surface side inclined surface 9b to the angle α formed between the virtual surface 7a and the front surface side inclined surface 8 at the edge 7 of the side surface portion 5 is θ / α. Therefore, the ratio β / α at the tip 3 is larger than the ratio θ / α at the side 5.

割合β/αが割合θ/αよりも大きいため、ナイフAによって眼球を刺通したとき、先端部3に作用する表面側と裏面側の力の差は、側面部5に作用する表面側と裏面側の力の差よりも小さくなる。従って、眼球に対しナイフAを軸方向に真っ直ぐに刺し込んだとき、先端部3では略直進させて切開することが可能であり、先端部3から側面部5に移行するのに伴ってナイフAは裏面方向に移動(下降)しつつ切開することが可能となる。   Since the ratio β / α is larger than the ratio θ / α, when the eyeball is pierced by the knife A, the difference in force between the front surface side and the back surface side acting on the tip portion 3 is different from the front surface side acting on the side surface portion 5. It becomes smaller than the difference in force on the back side. Therefore, when the knife A is inserted straight into the eyeball in the axial direction, the distal end portion 3 can be incised by being substantially straightly advanced, and the knife A is moved from the distal end portion 3 to the side surface portion 5. Can be incised while moving (lowering) in the direction of the back surface.

この結果、眼球に形成された切開創を正面からみたとき、先端部3による切開創は緩い曲線状となり、側面部5による切開創はより曲率の大きい下向きの曲線となる。そして、このような切開創によってフラウン切開を実現することが可能である。   As a result, when the incision formed in the eyeball is viewed from the front, the incision formed by the distal end portion 3 has a gentle curved shape, and the incision formed by the side surface portion 5 has a downward curve with a larger curvature. A Fraun incision can be realized by such an incision.

本件発明者等は、最大幅部4の寸法が2.4mm、尖端2から最大幅部4までの軸方向の寸法が3.0mm、先端部3の寸法が尖端2から軸方向に略0.5mm、側面部5の寸法が先端部3に連続して略3.0mm、尖端2を頂点とする一対のエッジ7どうしのなす角度が略60度、先端部3に於ける仮想面7aと表面側斜面8とのなす角度αを略21.5度、仮想面7aと裏面側斜面9aとのなす角度βを略11.5度とし、側面部5に於ける仮想面7aと表面側斜面8とのなす角度αを略21.5度、仮想面7aと裏面側斜面9bとのなす角度θを略9.5度とするナイフを作成した。   In the present inventors, the dimension of the maximum width portion 4 is 2.4 mm, the dimension in the axial direction from the tip 2 to the maximum width 4 is 3.0 mm, and the dimension of the tip 3 is approximately 0. 0 in the axial direction from the tip 2. 5 mm, the dimension of the side surface 5 is approximately 3.0 mm continuously from the tip 3, the angle between the pair of edges 7 having the tip 2 as the apex is approximately 60 degrees, the virtual surface 7 a and the surface at the tip 3 The angle α formed by the side slope 8 is approximately 21.5 degrees, the angle β formed by the virtual surface 7a and the back surface side slope 9a is approximately 11.5 degrees, and the virtual surface 7a and the surface side slope 8 in the side surface portion 5 are set. And a knife having an angle θ between the imaginary surface 7a and the back-side inclined surface 9b of approximately 9.5 degrees was created.

上記ナイフでは、先端部3に於ける割合β/αは0.53であり、側面部5に於ける割合θ/αは0.44である。従って、先端部3に於ける割合β/αが、側面部5に於ける割合θ/αよりも大きい。   In the knife, the ratio β / α at the tip 3 is 0.53, and the ratio θ / α at the side 5 is 0.44. Therefore, the ratio β / α at the tip 3 is larger than the ratio θ / α at the side 5.

上記の如く構成したナイフを用いて豚の眼球に対する切開創を形成する実験を行ったところ、尖端2から先端部3にかけての切開創は曲率の小さい緩い曲線状となり、側面部5の切開創は前記切開創と比較して曲率の大きい曲線状となった。この実験で得られた切開創は充分に好ましいフラウン切開といえる、との結論を得た。   When an experiment was performed to form an incision on the pig's eyeball using the knife configured as described above, the incision from the tip 2 to the tip 3 became a gentle curve with a small curvature, and the incision on the side 5 was A curved shape having a larger curvature than that of the incision was obtained. It was concluded that the incision obtained in this experiment was a sufficiently favorable Fraun incision.

次に第2実施例に係るナイフAの構成について図4を用いて説明する。尚、図に於いて、前述の第1実施例と同一の部分又は同一の機能を有する部分には同一の符号を付して説明を省略する。   Next, the configuration of the knife A according to the second embodiment will be described with reference to FIG. In the figure, the same portions as those in the first embodiment described above or portions having the same functions are denoted by the same reference numerals and description thereof is omitted.

本実施例では、裏面側斜面9であって、先端部3を構成する裏面側斜面9aから側面部5を構成する裏面側斜面9bに移行する部位に、境界線9cが形成されている。即ち、先端部3の裏面側斜面9aと側面部5の裏面側斜面9bとが連続的に接続されるものではなく、明確に形成された境界線9cを介して接続されている。このような裏面側斜面9a、9bは、高い剛性を有する研削材を利用し、ナイフの素材を予め設定された角度β、θに対応させて傾斜させて研削することで実現することが可能である。   In the present embodiment, a boundary line 9 c is formed at a portion of the back side slope 9 that transitions from the back side slope 9 a constituting the tip 3 to the back side slope 9 b constituting the side face 5. That is, the back surface side inclined surface 9a of the front end portion 3 and the back surface side inclined surface 9b of the side surface portion 5 are not continuously connected but are connected via a clearly formed boundary line 9c. Such back-side inclined surfaces 9a and 9b can be realized by using a grinding material having high rigidity and grinding the knife material in accordance with angles β and θ set in advance. is there.

上記の如く、裏面側斜面9a、9bが境界線9cを介して接続されていても、切開する際の刺通性に影響を与えることはなく、形成された切開創も先端部3では曲率の小さい緩い曲線状で、側面部5では前記切開創と比較して曲率の大きい曲線状となった。   As described above, even if the back side slopes 9a and 9b are connected via the boundary line 9c, the piercing property at the time of incision is not affected. It was a small, loosely curved shape, and the side surface portion 5 had a curved shape with a larger curvature than the incision.

尚、本実施例では、裏面側斜面9に於ける先端部3に対応する裏面側斜面9aから側面側斜面9bに移行する部位に境界線9cを形成するような構成とした。しかし、表面側斜面8に於ける先端部3に対応する範囲と側面部5に対応する範囲の角度を変更することで、先端部3に於ける割合β/αを側面部5に於ける割合θ/αよりも大きくするような場合、表面側斜面8に於ける先端部3と側面部5とを明確な境界線で接続しても良いことは当然である。   In the present embodiment, the boundary line 9c is formed at a portion of the back side slope 9 corresponding to the tip 3 from the back side slope 9a to the side slope 9b. However, the ratio β / α at the tip 3 is changed to the ratio at the side 5 by changing the angle between the range corresponding to the tip 3 on the front side slope 8 and the range corresponding to the side 5. When it is larger than θ / α, it is a matter of course that the front end portion 3 and the side surface portion 5 on the front surface side inclined surface 8 may be connected by a clear boundary line.

本発明に係るナイフAは、眼科手術に於ける自己閉鎖性の高い切開創を形成する際に利用することが可能である。   The knife A according to the present invention can be used when forming an incision with high self-closing property in ophthalmic surgery.

A ナイフ
1 刃部
2 尖端
3 先端部
4 最大幅部
5 側面部
7 エッジ
7a 仮想面
8 表面側斜面
9、9a、9b 裏面側斜面
9c 境界線
10 第2斜面
11 表面側平面
12 裏面側平面
A Knife 1 Blade part 2 Point 3 Tip part 4 Maximum width part 5 Side part 7 Edge 7a Virtual surface 8 Surface side slope 9, 9a, 9b Back side slope 9c Boundary line 10 Second slope 11 Surface side plane 12 Back side plane

Claims (3)

刃部の外周に沿ってエッジを形成した医療用ナイフであって、
刃部の平面投影形状が、刃部の先端部分に形成された尖端及び該尖端の近傍を含む先端部と、最も幅の広い最大幅部と、先端部と最大幅部の間に形成された側面部とからなる略三角形に形成され、
且つ刃部の外周に沿って形成されたエッジを含む仮想面を境界とし、表面側にエッジを構成する表面側斜面が、裏面側にエッジを構成する裏面側斜面が夫々形成されており、
前記先端部に於ける前記仮想面と前記表面側斜面とのなす角度に対する前記仮想面と前記裏面側斜面とのなす角度の割合が、前記側面部に於ける前記表面側斜面とのなす角度に対する前記仮想面と前記裏面側斜面とのなす角度の割合よりも大きいことを特徴とする医療用ナイフ。
A medical knife having an edge formed along the outer periphery of the blade part,
The planar projection shape of the blade portion was formed between the tip formed at the tip of the blade and the tip including the vicinity of the tip, the widest maximum width, and the tip and the maximum width. Formed in a substantially triangular shape consisting of side portions,
And the imaginary plane including the edge formed along the outer periphery of the blade part is used as a boundary, the front side slope that constitutes the edge on the front side, and the back side slope that constitutes the edge is formed on the back side, respectively.
The ratio of the angle formed by the virtual surface and the back surface side slope to the angle formed by the virtual surface and the surface side slope at the tip portion is relative to the angle formed by the surface side slope at the side surface portion. A medical knife characterized by being larger than a ratio of an angle formed by the virtual surface and the back-side slope.
前記仮想面を境界とし、該仮想面の表面側の厚みが前記裏面側の厚みよりも大きいことを特徴とする請求項1に記載した医療用ナイフ。 2. The medical knife according to claim 1, wherein the virtual surface is a boundary, and the thickness of the front surface side of the virtual surface is larger than the thickness of the back surface side. 前記仮想面と前記表面側斜面とのなす角度に対する前記仮想面と前記裏面側斜面とのなす角度の割合は、前記側面部では略一定であることを特徴とする請求項1又は2に記載した医療用ナイフ。   The ratio of the angle formed by the virtual surface and the back surface-side inclined surface to the angle formed by the virtual surface and the front surface-side inclined surface is substantially constant in the side surface portion. Medical knife.
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US16/325,722 US11304849B2 (en) 2016-08-29 2017-08-24 Knife for use in medical treatment
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RU2019108820A RU2744554C2 (en) 2016-08-29 2017-08-24 Knife for application in a medical procedure
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IL264600A IL264600B (en) 2016-08-29 2019-02-03 Knife for use in medical treatment
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